Nature Medicine : Fruquintinib plus paclitaxel for gastric/ gastroesophageal junction adenocarcinoma: the randomized phase 3 FRUTIGA trial

Fruquintinib plus paclitaxel versus placebo plus paclitaxel for gastric or gastroesophageal junction adenocarcinoma: the randomized phase 3 FRUTIGA trial

Feng Wang, Lin Shen, Weijian Guo, Tianshu Liu, Jin Li, Shukui Qin, Yuxian Bai, Zhendong Chen, Jufeng Wang, Yueyin Pan, Yongqian Shu, Fuyou Zhao, Ying Cheng, Feng Ye, Kangsheng Gu, Tao Zhang, Hongming Pan, Haijun Zhong, Fuxiang Zhou, Yanru Qin, Lei Yang, Weidong Mao, Qiu Li, Wenxiang Dai, Wei Li, Shubin Wang, Yong Tang, Dong Ma, Xianli Yin, Yanhong Deng, Ying Yuan, Man Li, Wenwei Hu, Donghui Chen, Guoxin Li, Qiqi Liu, Panfeng Tan, Songhua Fan, Michael Shi, Weiguo Su & Rui-Hua Xu

Abstract

The vascular endothelial growth factor pathway plays a key role in the pathogenesis of gastric cancer. In the multicenter, double-blind phase 3 FRUTIGA trial, 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy were randomized (1:1) to receive fruquintinib (an inhibitor of vascular endothelial growth factor receptor-1/2/3; 4 mg orally, once daily) or placebo for 3 weeks, followed by 1 week off, plus paclitaxel (80 mg/m² intravenously on days 1/8/15 per cycle). The study results were positive as one of the dual primary endpoints, progression-free survival (PFS), was met (median PFS, 5.6 months in the fruquintinib arm versus 2.7 months in the placebo arm; hazard ratio 0.57; 95% confidence interval 0.48–0.68; P < 0.0001). The other dual primary endpoint, overall survival (OS), was not met (median OS, 9.6 months versus 8.4 months; hazard ratio 0.96, 95% confidence interval 0.81–1.13; P = 0.6064). The most common grade ≥3 adverse events were neutropenia, leukopenia and anemia. Fruquintinib plus paclitaxel as a second-line treatment significantly improved PFS, but not OS, in Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma and could potentially be another treatment option for these patients. ClinicalTrials.gov registration: NCT03223376.

Citations and Links

Please follow the link below to access the publication:

Wang, F., Shen, L., Guo, W. et al. Fruquintinib plus paclitaxel versus placebo plus paclitaxel for gastric or gastroesophageal junction adenocarcinoma: the randomized phase 3 FRUTIGA trial. Nat Med (2024). https://doi.org/10.1038/s41591-024-02989-6

DOI: https://doi.org/10.1038/s41591-024-02989-6

Link to article: https://www.nature.com/articles/s41591-024-02989-6